JPMorgan Healthcare Conference

Transcription

1 JPMorgan Healthcare Conference Keith Grossman, Chief Executive Officer January 14, 2015

2 Disclosures Forward-Looking Statements This presentation includes forward-looking statements, including our current expected timelines for product development, clinical trials and commercialization. Forward-looking statements should not be read as a guarantee of future performance or results, and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to those discussed from time to time in Thoratec s public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, Risk Factors, in Thoratec s most recent annual report on Form 10-K and quarterly report on Form 10-Q, and as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof. Statement on Product Risk Please consult the HeartMate II and CentriMag Instructions for Use, for indications for use, contraindications, warnings and adverse events. Individual experiences, symptoms, situations and circumstances may vary. Possible serious adverse events include: neurological problems (such as stroke), infection, bleeding, device malfunction (pump replacement), kidney and liver dysfunction, right heart failure, depression or anxiety and death. Pipeline Programs Pipeline programs, including the HeartMate III and HeartMate PHP, are in development and not approved for use. The HeartMate III is an investigational device and is limited by Federal (or United States) law to investigational use. Trademarks Thoratec, the Thoratec logo, HeartMate, HeartMate II, and GoGear are registered trademarks of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH. HeartMate III, HeartMate PHP, HeartMate X, PVAD, IVAD, Pocket Controller, Mobile Power Unit, MagLev, Shared Care, Thoratec Connect, Thoratec 360, ASC, and SIS are trademarks of Thoratec Corporation or its affiliates. DuraHeart is a registered trademark of Terumo Corporation. 2

3 Agenda Thoratec Overview Chronic Products Acute Products A Look Ahead

4 Thoratec: The Leader in Mechanical Circulatory Support A Growing and Still Under-Penetrated Market for Heart Failure Patients Acute Support * Improved Outcomes Less Invasive Fully Implantable * Chronic Support 4 Early Generations HeartMate II HeartMate III Future Generations *CAUTION HeartMate III is an investigational device and is limited by Federal (or United States) law to investigational use. HeartMate PHP is currently in development and not approved for sale.

5 Attractive Long-Term Growth Profile Revenue by Geography ($ Millions) $600 Non-GAAP EPS $2.10 $500 $400 $300 CAGR: U.S. +24% Int l +20% Total +23% HMII U.S. BTT Approval $215 $280 $55 HMII U.S. DT Approval $383 $66 $423 $75 $492 $503 $91 $112 $1.75 $1.40 $1.05 HMII U.S. BTT Approval $0.86 HMII U.S. DT Approval $1.23 $1.56 $1.83 $1.80 $200 $100 $144 $37 $107 $47 $168 $225 $317 $348 $401 $391 $0.70 $0.35 $0.33 $0.61 $ $ U.S. International Note: GAAP EPS results were $0.06, $0.39, $0.50, $0.99, $1.20, $0.94, and $1.26 in respectively. Note: Revenue figures exclude ITC Division in all periods. 5

6 Agenda Thoratec Overview Chronic Products * * Acute Products A Look Ahead *CAUTION HeartMate III is an investigational device and is limited by Federal (or United States) law to investigational use. HeartMate PHP and the Apica VAD SIS are currently in development and not approved for sale.

7 HeartMate II : Left Ventricular Assist System The most widely used, extensively studied LVAD Tested over 1,300 patient clinical trial (BTT & DT) and extensive post-market study experience with highly challenging patient populations. Proven over 18,000 patients implanted > 7,000 patients on ongoing support > 400 published, peer-reviewed articles Reliable 3,000 patients with 2+ years of support Longest patient has been on support for over a decade Data on file as of 3Q14. 7

8 VAD Market Development: The HeartMate II Era HeartMate II has begun to address the significant unmet need for advanced-stage heart failure patients driving increased BTT penetration, as well as growing adoption within the DT patient population Thoratec: VAD Units Shipped (Worldwide) DT as a % of U.S. HeartMate II Implants 1 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1,000 1,728 1,712 1,222 1,054 2, , ,012 3, ,820 3, ,149 4,097 3, ,858 3,846 70% 60% 50% 40% 30% 20% 20% 30% 40% 45-50% 60% >60% , % 0% HeartMate II Prior Generations (1) Source: Thoratec estimates, based on center reporting data. 8

9 Growth Driven by Tremendous Benefits of Therapy Bridge-to-Transplantation Six-Minute Walk Test (6MWT) 1,2 Improvement in NYHA Functional Class Over Time 3 Only 16% could complete pre implant 94% could complete post implant Bridge to Transplantation at 6 Months 100% 75% 50% 25% Can t Walk Can Walk 0% 100% Baseline 6 Months Destination Therapy at 2 Years 75% 50% 25% Could not complete 345 m average 0% Baseline NYHA IV 2 Years NYHA II 1. John, Naka, Smedira, et al. Ann Thorac Surg 2011; 92: Data on file. 3. Park, Milano, Tatooles, et al. Circulation Heart Failure. 2012; 5: NYHA III NYHA I

10 HeartMate II : Continued Improvement in Survival 1-Year Survival Rates Bridge-to-Transplant 1 Destination Therapy 2 85% 74% 73% 74% 68% 68% Trial CAP Post Approval Trial CAP Post Approval 1. Miller, Pagani, Russell, et al. NEJM 357: , Pagani, Miller, Russell, et al. JACC 54: , Starling, Naka, Boyle, et al. JACC 57:1890-8, Slaughter, Rogers, Milano, et al. NEJM 2009; 361: Park, Milano, Tatooles, et al. Circ HF 2012; 5: Jorde, Kushwaha, Tatooles, et al. JACC 2014; 63:

11 Leading the Field with HeartMate II Post-Market Studies Post-Market Study Focus Highlights ROADMAP HMII in slightly less sick patients Data to be presented in Spring 2015 SEE-HF TRACE SSI Improved patient screening and identification Reduced anti-coagulation Driveline infection Data to be presented in 2015 Submitted 1-year data for publication; 2-year data in Spring 2015 Manuscript accepted in JHLT showing 50% reduction in infection PREVENT Pump thrombosis Enrollment ongoing Ongoing clinical program to expand the addressable market and reduce barriers to growth. 11

12 Although Adverse Events Remain a Barrier to Growth 82% 12 Month Survival 80% 78% 76% 74% Patient survival has improved slightly despite a higher mix of sicker DT patients although total readmission rates remain a burden. Top drivers of readmissions: Bleeding All Cause Readmissions Per Patient Year Stroke Thrombus 72% Month Survival All Cause Hospital Readmissions Source: INTERMACS data for HeartMate II through 2Q14 12

13 Multiple Factors Impact Market Growth Some market growth challenges can be addressed through execution in the near-term New Technology Center Capacity Development Referral Generation Market Growth Geographic Expansion Clinical Data & Guidelines Outcomes Improvement although others will take longer to resolve All barriers to growth are ultimately addressable. 13

14 HeartMate III TM : The Next Generation The first fully magnetically levitated compact VAD Revolutionary maglev technology over a decade in development * Design Objectives Reduced adverse events Compact size for less invasive surgical approaches Return of pulsatility into continuous flow profile *CAUTION HeartMate III is an investigational device and is limited by Federal (or United States) law to investigational use. See Pipeline Programs disclosure on Slide 2. 14

15 HeartMate III TM : Full MagLev TM Technology Expected Benefits of Full MagLev Full support (flow) up to 10L/minute at lower pump speeds Large gaps allow for thorough washing and avoidance of blood trauma (shear) Active gap control Pump gaps are not dependent on pump speed Electromagnets constantly maintain rotor location to ensure consistent gap size Pulsatile flow Smaller pump, less invasive surgical implantation *CAUTION HeartMate III is an investigational device and is limited by Federal (or United States) law to investigational use. See Pipeline Programs disclosure on Slide 2. 15

16 Leading the Field to Next Generation Therapy HMIII CE Mark Study (enrollment complete) 50 patient trial at 10 sites in Europe and Australia Completed enrollment in November 2014 Primary Endpoint of survival on HeartMate III support at six months Less invasive implant studies planned for 2015 Fall 2015 data readout Expect European launch in late 2015 HMIII U.S. IDE Study (currently enrolling) Over 1,000 patients at up to 60 U.S. sites (23 enrolled as of January 2015) Single study design for short and long term use First 294 patients with six month follow up First 366 patients with two year follow up Approximately 600 additional patients to evaluate Secondary Endpoints Non-inferiority study randomized 1:1 against HeartMate II Primary Endpoints: Survival on HeartMate III support free of stroke or pump replacement *CAUTION HeartMate III is an investigational device and is limited by Federal (or United States) law to investigational use. See Pipeline Programs disclosure on Slide 2. 16

17 Apica: A Unique Implant Technology Product Overview: Simplified apical access and attachment Currently in development Based on technology from a CE Mark approved TAVR device Clinical Advantages and Differentiation: Designed to enable less invasive and off pump LVAD implantation Standardized and replicable less invasive implant technique Apica VAD Surgical Implant System SIS Proprietary technology will only be available with Thoratec pumps * *CAUTION The Apica VAD SIS is currently in development and not approved for sale. See Pipeline Programs disclosure on Slide 2. 17

18 Agenda Thoratec Overview Chronic Products Acute Products * A Look Ahead *CAUTION HeartMate PHP is currently in development and not approved for sale.

19 Acute Surgical MCS: A Growing Market Worldwide demand for acute surgical circulatory support devices is expected to exceed $250M by 2018 CentriMag and PediMag hold a leadership position in worldwide acute MCS market Annualized revenue of $50M+ >10,000 implants worldwide Over 200 implanting centers in the U.S. and over 300 worldwide Worldwide Acute Surgical Market ($ Millions) $300 $225 $150 $75 $0 $35 $25 Growth driven primarily by increase in ECMO $145 $50 $95 $105 CentriMag/PediMag U.S. Revenue ($ Millions) $22.2 $26.0 $ VAD Solid double-digit growth profile ECMO $270 $30.9 $17.8 $ Data and estimates on file. 19 CentriMag/PediMag

20 CentriMag : Full MagLev TM Acute Support Only commercially available acute surgical circulatory support device featuring full magnetic levitation Contact-free blood chamber No bearings, shafts, or seals MagLev technology shared with Heartmate III CentriMag PediMag Adult and Pediatric pumps operate on a common hardware platform Pursuing pathway for U.S. 30-day indication for use Exploring integrated ECMO solutions 20

21 Large Market Opportunity for Acute Percutaneous Support Large worldwide market opportunity with over 100,000 patients treated annually with acute percutaneous MCS. Primary Indications for Percutaneous Support IABP is currently the most widely used device and standard of care Additional patients currently treated by medical management HR PCI Cardiogenic Shock ADHF Failure to Wean $1 billion+ opportunity for novel device therapy Recent studies including SHOCK II have questioned the effectiveness of IABP Clinicians are searching for new options to rapidly stabilize hemodynamically compromised acute heart failure patients 21

22 HeartMate PHP TM : A Novel Acute MCS Therapy Catheter-based percutaneous heart pump delivered through 14F introducer; expands to 24F when unsheathed Cannula Inlet Coated Cannula Designed to deliver > 4 lpm of flow at low RPMs Breaking the Link Between Size and Flow* * Impeller Cannula Outlet Low Flow Rates (LPM) High IABP Impella 2.5 PHP Impella CP Tandem Heart Smaller Insertion Profile *CAUTION HeartMate PHP is currently in development and not approved for sale. Seyfarth, Sibbing, et al. J Am Coll Cardiology. 2008;52(19): Impella and Tandem Heart estimates based on manufacturer labeling. PHP estimates based on preclinical bench testing. See Pipeline Programs disclosure on Slide Impella 5.0 Larger

23 HeartMate PHP TM : Clinical Studies Underway First-in-Human experience completed in 2013 Pivotal CE Mark study currently enrolling; expect approval in 2015 Up to 50 patients undergoing high-risk PCI (HRPCI) Primary endpoints: avoidance of major adverse events at 30 days, device and procedural success Pivotal US IDE expected to begin in 2015 *CAUTION HeartMate PHP is currently in development and not approved for sale. See Pipeline Programs disclosure on Slide 2. 23

24 Agenda Thoratec Overview Chronic Products Acute Products A Look Ahead

25 Looking Ahead Will Be A Transition Year: Primary Headwinds Uncertain timing of market growth reacceleration Market share still settling out entering 2015 Notable Positives HeartMate III trial enrollment in the U.S. HeartMate III CE Mark approval in late 2015 Longer-term growth outlook remains positive: Large addressable market Ability to capitalize on future opportunities 25

26 Thank you. 26